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ClinicalTrials.gov ID

NCT06837974

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

180Estimated

Last Update Posted

Feb 20, 2025Actual

Start Date

Jul 1, 2025Estimated

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Oct 31, 2026Estimated

Official Title

Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial

Brief Summary

The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are:

• Does the AI model lower the number of punctures, radiation dose, and complications of participants undergo TIPS?
• Does the AI model improve the efficacy of TIPS for participants?

Participants will:

• Take the TIPS by the guidance of the AI model or conventional manually blinded penetration (placebo)
• The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded
• Intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after TIPS will be reported

• Portal Hypertension Related to Cirrhosis

• AI guided TIPS
• Artificially blinded TIPS

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
• Participants whose physical condition is suitable for TIPS.

Exclusion Criteria:

• Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
• Participants are pregnant or breastfeeding.
• Participants are unwilling or unable to sign informed consent.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

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